Spinal Anesthesia-induced HypotensionNCT07057362
Effect of Vitamin D Deficiency on the Frequency and Severity of Spinal Anesthesia-Induced Hypotension in Pregnant Women Undergoing Cesarean Section
An observational study of Spinal Anesthesia-induced Hypotension and Vitamin D Deficiency, run by Duzce University at 1 site in Turkey (Türkiye).
Trial summary
Spinal anesthesia-induced hypotension remains a common and significant complication during cesarean sections, posing risks for both mother and fetus. Vitamin D deficiency, frequently observed in pregnant women, is associated with altered vascular function and potential hemodynamic instability. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Spinal Anesthesia-induced Hypotension, Vitamin D Deficiency, Cesarean Section
- What is being tested?
- Intraoperative Hemodynamic Monitoring
- How many people
- 177 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 30 Dec 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women aged 18 years and older who are scheduled for elective cesarean section under spinal anesthesia at a tertiary care university hospital. All participants will be clinically stable and provide informed consent prior to enrollment. The study population will be stratified based on serum vitamin D levels into deficient and sufficient groups for analysis of hypotension outcomes.
Who may be able to join
- Pregnant women aged 18 years or older
- Scheduled for elective cesarean delivery under spinal anesthesia
- Able and willing to provide written informed consent
Who cannot join
- Emergency cesarean sections
- History of significant cardiovascular disease (e.g., arrhythmia, heart failure)
- Known neurological disorders affecting autonomic function
- Current vitamin D supplementation within the past 30 days
- Inability to undergo blood sampling or provide valid hemodynamic data
- Contraindication to spinal anesthesia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Duzce University Faculty of Medicine, Department of Anesthesiology and Reanimation
Düzce, Merkez
About this study
Spinal anesthesia-induced hypotension remains a common and significant complication during cesarean sections, posing risks for both mother and fetus. Vitamin D deficiency, frequently observed in pregnant women, is associated with altered vascular function and potential hemodynamic instability. This prospective observational study aims to investigate whether vitamin D deficiency is associated with an increased incidence and severity of spinal anesthesia-induced hypotension in pregnant women undergoing elective cesarean delivery. Vitamin D levels will be measured preoperatively, and intraoperative hemodynamic parameters will be closely monitored. The findings could contribute to improved management strategies for pregnant patients at risk of severe hypotension.
Read the detailed description
Detailed Description Spinal anesthesia is the most commonly used technique for cesarean section and is associated with a high incidence of maternal hypotension, which can adversely affect both maternal well-being and neonatal outcomes. Despite standard preventive strategies such as fluid preloading and vasopressor use, significant hypotension still occurs in a considerable proportion of patients.
Vitamin D deficiency is a prevalent condition among pregnant women and has been implicated in the modulation of cardiovascular and autonomic functions. Low serum levels of 25-hydroxyvitamin D may impair vascular smooth muscle contractility, endothelial function, and baroreflex sensitivity, potentially contributing to exaggerated hypotensive responses under spinal anesthesia.
This prospective observational study aims to evaluate the relationship between maternal vitamin D status and the incidence and severity of spinal anesthesia-induced hypotension during elective cesarean delivery. Eligible pregnant women scheduled for elective cesarean section under spinal anesthesia will have their serum 25-hydroxyvitamin D levels measured preoperatively. Intraoperative hemodynamic parameters will be continuously monitored, and episodes of hypotension will be recorded and analyzed in relation to vitamin D status.
The primary outcome of the study is the incidence of spinal hypotension, defined as a ≥20% decrease in systolic blood pressure from baseline or an absolute value below 90 mmHg. Secondary outcomes include total vasopressor dose, fluid requirement.
Findings from this study may identify vitamin D deficiency as a novel risk factor for spinal anesthesia-induced hypotension and inform new preventive strategies for hemodynamic management in cesarean deliveries
- Being tested
- Intraoperative Hemodynamic Monitoring
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Hemodynamic MonitoringOther
Continuous intraoperative monitoring of systolic blood pressure and heart rate following spinal anesthesia. Vasopressor usage and total fluid administration will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D Deficient Group | Pregnant women with serum 25-hydroxyvitamin D levels below the defined deficiency threshold Receives: Other: Intraoperative Hemodynamic Monitoring | |
| Vitamin D Sufficient Grup | Pregnant women with normal or sufficient vitamin D levels Receives: Other: Intraoperative Hemodynamic Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Hypotension After Spinal Anesthesia
Hypotension is defined as a ≥20% decrease in systolic blood pressure from baseline or an absolute systolic value <90 mmHg. The presence or absence of hypotension will be recorded.
Measured: ntraoperative (0-30 minutes after spinal anesthesia)
Secondary outcomes (2)
Total Vasopressor Dose Administered
Cumulative amount (in mg) of vasopressor (e.g., ephedrine or phenylephrine) used to manage hypotension.
Measured: Intraoperative (during operation)
Total Crystalloid Volume Administered
Total amount (in mL) of intravenous crystalloids given from the time of spinal anesthesia until delivery.
Measured: Intraoperative (during operation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start1 Mar 2025
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Anesthesia-induced HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 177 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057362
- Sponsor's protocol ID
- 2025/63
- Status last verified
- Oct 2026
- First submitted
- 30 Jun 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study involves sensitive clinical data from pregnant women. Individual participant data will not be shared publicly due to privacy concerns.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D Deficiency on the Frequency and Severity of Spinal Anesthesia-Induced Hypotension in Pregnant Women Undergoing Cesarean Section
- ClinicalTrials.gov ID
- NCT07057362
- Acronym / sponsor ID
- 2025/63
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 9 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Spinal anesthesia-induced hypotension remains a common and significant complication during cesarean sections, posing risks for both mother and fetus. Vitamin D deficiency, frequently observed in pregnant women, is associated with altered vascular function and potential hemodynamic instability. This prospective observational study aims to investigate whether vitamin D deficiency is associated with an increased incidence and severity of spinal anesthesia-induced hypotension in pregnant women undergoing elective cesarean delivery. Vitamin D levels will be measured preoperatively, and intraoperative hemodynamic parameters will be closely monitored. The findings could contribute to improved management strategies for pregnant patients at risk of severe hypotension.
Detailed description
Detailed Description Spinal anesthesia is the most commonly used technique for cesarean section and is associated with a high incidence of maternal hypotension, which can adversely affect both maternal well-being and neonatal outcomes. Despite standard preventive strategies such as fluid preloading and vasopressor use, significant hypotension still occurs in a considerable proportion of patients.
Vitamin D deficiency is a prevalent condition among pregnant women and has been implicated in the modulation of cardiovascular and autonomic functions. Low serum levels of 25-hydroxyvitamin D may impair vascular smooth muscle contractility, endothelial function, and baroreflex sensitivity, potentially contributing to exaggerated hypotensive responses under spinal anesthesia.
This prospective observational study aims to evaluate the relationship between maternal vitamin D status and the incidence and severity of spinal anesthesia-induced hypotension during elective cesarean delivery. Eligible pregnant women scheduled for elective cesarean section under spinal anesthesia will have their serum 25-hydroxyvitamin D levels measured preoperatively. Intraoperative hemodynamic parameters will be continuously monitored, and episodes of hypotension will be recorded and analyzed in relation to vitamin D status.
The primary outcome of the study is the incidence of spinal hypotension, defined as a ≥20% decrease in systolic blood pressure from baseline or an absolute value below 90 mmHg. Secondary outcomes include total vasopressor dose, fluid requirement.
Findings from this study may identify vitamin D deficiency as a novel risk factor for spinal anesthesia-induced hypotension and inform new preventive strategies for hemodynamic management in cesarean deliveries
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D Deficient Group | – | Other: Intraoperative Hemodynamic MonitoringPregnant women with serum 25-hydroxyvitamin D levels below the defined deficiency threshold |
| Vitamin D Sufficient Grup | – | Other: Intraoperative Hemodynamic MonitoringPregnant women with normal or sufficient vitamin D levels |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women aged 18 years and older who are scheduled for elective cesarean section under spinal anesthesia at a tertiary care university hospital. All participants will be clinically stable and provide informed consent prior to enrollment. The study population will be stratified based on serum vitamin D levels into deficient and sufficient groups for analysis of hypotension outcomes.
Key inclusion criteria (3 listed)
- Pregnant women aged 18 years or older
- Scheduled for elective cesarean delivery under spinal anesthesia
- Able and willing to provide written informed consent
Key exclusion criteria (6 listed)
- Emergency cesarean sections
- History of significant cardiovascular disease (e.g., arrhythmia, heart failure)
- Known neurological disorders affecting autonomic function
- Current vitamin D supplementation within the past 30 days
- Inability to undergo blood sampling or provide valid hemodynamic data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative Hemodynamic MonitoringContinuous intraoperative monitoring of systolic blood pressure and heart rate following spinal anesthesia. Vasopressor usage and total fluid administration will be recorded. | Other | Vitamin D Deficient Group, Vitamin D Sufficient Grup |
Primary outcome
Incidence of Hypotension After Spinal Anesthesia
Time frame: ntraoperative (0-30 minutes after spinal anesthesia)
Hypotension is defined as a ≥20% decrease in systolic blood pressure from baseline or an absolute systolic value <90 mmHg. The presence or absence of hypotension will be recorded.
2 secondary outcomes
Total Vasopressor Dose Administered
Time frame: Intraoperative (during operation)
Total Crystalloid Volume Administered
Time frame: Intraoperative (during operation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No. The study involves sensitive clinical data from pregnant women. Individual participant data will not be shared publicly due to privacy concerns.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Anesthesia-induced Hypotension and Vitamin D Deficiency, run by Duzce University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Hypotension After Spinal Anesthesia (time frame: ntraoperative (0-30 minutes after spinal anesthesia)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.